FDA recall: a tube-feeding formula subpotent for vitamin A — the cause was not manufacturing but a testing laboratory using the wrong method (Nutricia North America)
A plant-based peptide formula was recalled as subpotent for vitamin A. The cause was not a manufacturing fault but a testing laboratory using the wrong method, which reported a higher concentration than the product actually contained. It shipped to 48 US states and also to Canada and Australia.
Recall overview (primary data)
- ClassificationClass II
- Product typeFood
- Recalling firmNutricia North America
- ReasonSubpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a higher concentration of vitamin A than what is actually in the product.
- DistributionProduct was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK,...
- Recall initiated2026-05-26
Key points
- A plant-based peptide meal replacement formula was recalled as subpotent for vitamin A.
- The cause was not a manufacturing fault but a testing laboratory using the wrong method for vitamin A.
- The record states the test results gave a higher concentration than the product actually contains.
- Quantity was 2,050 cases plus 55,310 cases, shipped to 48 US states and Washington DC, and also to Canada and Australia.
- Of the 1,408 records this site holds as of 2026-08-31, 2 touch on a wrong test method; subpotency appears in 36, out-of-specification in 12, and CGMP deviations in 75.
1The test was wrong, not the product
Recall reasons are usually explained by what happened to a product: foreign matter got in, an organism was detected, a component ran high or low. What this record cites is none of those. A testing laboratory measured by the wrong method. The readings came out higher than reality, so shipping continued under a judgment that specification had been met.
Even with nothing changed on the product side, a different way of measuring changes the pass-or-fail result. It is a case where the premise that quality control is functioning had itself given way.
2Who eats this matters
The product is not an ordinary food but a peptide formula that replaces meals. Products of this kind are built on the assumption that someone who cannot readily eat by mouth takes all, or most, of their nutrition from them. Nutrients meeting specification is therefore not a question of taste or texture but of whether requirements are met.
That a vitamin A shortfall is handled as Class II reflects a classification judgment that serious harm is not immediate, but the product being one taken continuously over time shapes the character of the record.
3Wrong test method appears in 2 of 1,408 records
Sorting the 1,408 FDA recall records this site holds as of 2026-08-31 by the wording of their reasons, only 2 touch on a wrong test method. Subpotency itself is cited by 36, out-of-specification results by 12, and deviations from CGMP by 75. Manufacturing deviations are recorded repeatedly, while cases stating expressly that the measurement side was wrong are exceedingly rare.
That is not necessarily because measurement rarely goes wrong: a faulty measurement passes as no anomaly, which makes it hard to discover.
Why it matters
Quality control rests on measurement being correct. Where the method is wrong, the judgment that specification was met loses meaning, and nothing surfaces as an anomaly. Validating the test method is a requirement separate from verifying the manufacturing process, and where testing is outsourced, that verification falls inside the scope of management too.
FAQ
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Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: H-1153-2026